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"The completion of patient recruitment in our Phase2b EDELWEISS clinical trial is a testament to our clinical research and operations teams, and underscores
Approximately 330 patients are expected to be randomized in the EDELWEISS clinical trial, and primary endpoint efficacy results continue to be anticipated in mid-2018.
About the EDELWEISS Clinical Trial
EDELWEISS is a Phase 2b, randomized, double blind clinical trial assessing multiple dosages of OBE2109 compared to placebo for the treatment of pain associated with endometriosis. The primary endpoint is patient response following 12 weeks of treatment, defined as at least 30% improvement in combined menstrual and non-menstrual pain as measured by a four point verbal rating scale (VRS). The goal of this trial is to set the foundation for
Endometriosis is a disease in which the endometrium (tissue lining the inside of the uterus) grows outside of the uterus, where it induces a chronic inflammatory reaction in the abdomen that may result in scar tissue. It is primarily found on the pelvic peritoneum, on the ovaries, in the rectovaginal septum, on the bladder and in the bowels. The most common symptom of endometriosis is pelvic pain, which often correlates to the menstrual cycle. Patients may also experience painful ovulation, pain during or after sexual intercourse, heavy bleeding, chronic pelvic pain, fatigue and infertility. For many, endometriosis pain can be so severe and debilitating that it impacts day-to-day activities and has a negative effect on general physical, mental and social well-being.
OBE2109 is a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. OBE2109 acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. Through previously reported results from this class of drugs and sophisticated pharmacological modelling, it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression.
Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney - dialysis and Unmet Medical Needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D.
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